
Tusker Medical, Inc.
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Tula Tympanostomy Tube Delivery Device is an FDA 510(k)-cleared medical device (K252436) manufactured by Tusker Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2026. Regulation: 8.

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